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This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of EZH2 inhibitor Zeprumetostat in combination therapy for patients with relapsed or refractory mature T-cell and NK-cell lymphomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zeprumetostat Combined with Golidocitinib or Chidamide | Experimental | In Cohort 1, patients will receive Zeprumetostat in combination with Golidocitinib, with an initial dose of 350mg of Zeprumetostat. Each treatment cycle is 28 days. The Zeprumetostat will be combined with Golidocitinib at the RP2D dose level for an extension study. In Cohort 2, patients will receive Zeprumetostat in combination with Chidamide, with an initial dose of 350mg of Zeprumetostat. Each treatment cycle is 28 days. The Zeprumetostat will be combined with Chidamide at the RP2D dose level for an extension study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zeprumetostat | Drug | 350mg, po, bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DLT for Phase 1b | To identify the dose-limiting toxicity | The first cycle after administration (each cycle is 28 days) |
| Overall response rate(ORR) for Phase 2 | The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response. | Up to 24 months |
| RP2D for phase Ib | To identify the recommended phase 2 dose | The first cycle after administration (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Defined as the proportion of patients who achieve complete remission as the best response | Up to 24 months |
| Duration of Response(DOR) | To investigate the preliminary anti-tumor efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | +862087342823 | caiqq@sysucc.org.cn |
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| Golidocitinib |
| Drug |
Cohort 1: Golidocitinib: 150mg, po, qd |
|
| Chidamide | Drug | Cohort 2: Chidamide: 20mg, po, biw |
|
| Up to 4 years |
| Progression-free survival(PFS) | To investigate the preliminary anti-tumor efficacy | Up to 4 years |
| Overall survival(OS) | To investigate the preliminary anti-tumor efficacy | Up to 4 years |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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